Primary Function of the Position
The New Product Verification Department is devoted to assuring safe reliable and effective products that exceed patient surgeon and hospital expectations. The department plays a vital role in product and process quality in new product development and production and in the quality of da Vinci and Ion robotic product lines including diagnostic systems endoscopic instrumentation and supporting accessories. The Senior Test Engineer will work with a team of dedicated people within a product development team to assure the quality of new designs to identify issues related to new designs and processes and to work with other Test Engineers to develop harmonized test methods.
Essential Job Duties
Test Protocol Development & Reporting
- Develops high level test plans for instrument accessories endoluminal and vision projects
- Generates and takes ownership of test protocols for Design Verification and Life/ Reliability tests
- Develops clinically relevant test methods ensure design requirements are sufficiently verified by collaborating with appropriate cross functional partners
- Executes test protocols for clinicallybased surgical simulation and automated testing utilizing da Vinci surgical system Ion Systems and/or other test equipment
- Identifies reports and negotiate problems that arise during feasibility and design verification testing and escalates new or persistent failure modes to appropriate engineering teams
- Proactively engages with appropriate engineering teams and drives failure investigation and root cause analysis
- Clearly documents test results and observations in test report.
Test Fixture Development:
- Designs test fixtures and other test aids needed to perform Design Verification and Life/ Reliability tests
- Proactively identifies and develops processes and test methods that could benefit from new or updated fixture designs by engaging with design and test engineers
Reasoning Ability:
- Ability to apply critical thinking to solve problems while leading crossfunctional technical teams in making recommendations.
- Ability to influence technical stake holders and suggest process improvements
- Ability to understand and work on complex products and processes
Other Responsibilities
- Ability to collaborate with cross functional teams and contribute to the development of product requirements and risk documents
- Effective technical communication across various levels of the organization at core team meetings and design reviews.
- Ensures successful ontime completion of department and core team projects; communicates constraints and recommends preferred mitigation to direct management when successful project completion is at risk
- Complies with company Department and Standard Operating Procedures
- Effectively translate the functional requirements into appropriate acceptance criteria for testcases and test methods.
- Train test technicians on test methods and procedures
Qualifications :
Required Skills and Experience
- Medical Device Verification/Validation experience is required
- Understanding of design controls used in the Medical device development is required.
- Ability to perform mechanical engineering calculations needed to support equipment design including dimensional analysis.
- Experience using tools and measuring equipment (Force Gauge Calipers Instron Oscilloscopes etc..
- Ability to work autonomously and with minimal supervision.
- Ability to multitask and handle tasks with contesting priorities effectively.
- Ability to work with biological samples including blood tissue and organs.
- Familiar with GDP skills.
- Accepting and adhering to high ethical moral and personal values in actions communications actions and when dealing with others
Required Education and Training
- Minimum of 6 years experience working in an engineering or research team environment.
- Minimum BS in Mechanical Biomedical Engineering or similar degree. MS preferred.
Working Conditions
- The employee will spend time at their desk in front of the computer as well as work in a lab environment.
- Lab environment will have exposure to animal blood and tissue; there will also be exposure to detergents and other chemicals used for reprocessing medical devices.
- Hands on testing includes but not limited to using the robotic systems mechanical test fixtures microscopes electrical test fixtures etc.
Preferred Skills and Experience
- Prefer experience within medical device or pharmaceutical industry.
- Experience with working through various phases of medical device product development process (concept through launch) is preferred.
- Experience with SolidWorks or similar CAD software.
- Experience with MATLAB Python Arduino is highly preferred.
- Experience working with electromechanical systems is a plus.
- Experience with Test Method Validation is highly preferred.
- Experience in Reliability Engineering is a plus.
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
EEO and AA Policy
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Fulltime